healthy male and female
Conditions
Interventions
midazolam (oral), wash out, midazolam (iv)
Sponsors
Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The investigators must ensure that all subjects being considered meet the following inclusion criteria: 1) Japanese healthy male or female who is capable to understand and sign the informed consent 2) 20-45 years of age 3) BMI 17.6-26.4 4) good health as determined by physical examination, vital signs and laboratory tests.
Exclusion criteria
Exclusion criteria: The investigators must ensure that all subjects being considered meet the following exclusion criteria or conditions: 1) history of allergy to any drugs 2) medical attention within 2 months prior to participation 3) donation of 200 mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation 4) donation of 400 mL or more of blood within 12 weeks prior to participation 5) recent (past 4 months) participation in other clinical trial for investigational new chemical entity 6) history of drug abuse 7) alcohol abuse 8) taking drugs or healthy foods which may affect drug metabolism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics of midazolam, DNA methylation levels in hepatic derived cells, and disposition of endogenous compounds | — |
Countries
Japan
Contacts
Public ContactMiyuki Kimura
LTA Fukuoka Mirai Hospital
Outcome results
None listed